Behavior Problems, ChildEPICNCT01517867
Early Parenting Intervention Comparison
A study testing Chicago Parent Program and Parent-Child Interaction Therapy in people with Behavior Problems, Child, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problems, Child
- What is being tested?
- Chicago Parent Program and Parent-Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child 2 to 5 years old
- parent reports reason for referral is child behavior problems
- parent is a biological or adoptive parent, or legal guardian of child
Who cannot join
- parent is psychotic or actively abusing substances
- child is autistic or severely developmentally delayed
Trial locations and contacts
1 site in 1 country.
United States1 site
The Family Center at Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: Comparing Two Parenting Programs for At-Risk Families
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.
- Conditions
- Behavior Problems, Child
- Being tested
- Chicago Parent Program, Parent-Child Interaction Therapy
- Keywords
- preschool children behavior problems, child between 2 and 5 years old
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicago Parent ProgramBehavioural
The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
Parent-Child Interaction TherapyBehavioural
Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
| Study group | Role | What they receive |
|---|---|---|
| Intervention Chicago Parent Program arm | Experimental | The Chicago Parent Program is a 12-session group-based parenting skills training program Receives: Behavioral: Chicago Parent Program |
| Parent-Child Interaction Therapy | Active comparator | Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems Receives: Behavioral: Parent-Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Behavior Problems
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
Measured: baseline, first follow-up (up to 2 years)
Secondary outcomes (1)
Aggregate Cost
Combined provider (based on billing records) and parent cost (based on self-report).
Measured: through end of study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavior Problems, ChildStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Iowa, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Deborah Gross, DNSc, Principal investigator, Johns Hopkins University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517867
- Sponsor's protocol ID
- NA_00039328
- Other IDs
- R01NR012444
- Acronym
- EPIC
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2012
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data sharing plan was developed.
Publications
Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.
PubMed 30768419Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.
PubMed 24581245
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Parenting Programs for At-Risk Families
- ClinicalTrials.gov ID
- NCT01517867
- Acronym / sponsor ID
- EPIC / NA_00039328
- Conditions
- Behavior Problems, Child
- Keywords
- preschool children behavior problems, child between 2 and 5 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc., University of Iowa, National Institute of Nursing Research (NINR)
- Study start
- Sep 2011 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Chicago Parent Program arm | Experimental | Behavioral: Chicago Parent ProgramThe Chicago Parent Program is a 12-session group-based parenting skills training program |
| Parent-Child Interaction Therapy | Active comparator | Behavioral: Parent-Child Interaction TherapyParent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child 2 to 5 years old
- parent reports reason for referral is child behavior problems
- parent is a biological or adoptive parent, or legal guardian of child
Key exclusion criteria (2 listed)
- parent is psychotic or actively abusing substances
- child is autistic or severely developmentally delayed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chicago Parent ProgramThe Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems | Behavioural | Intervention Chicago Parent Program arm |
| Parent-Child Interaction TherapyParent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems | Behavioural | Parent-Child Interaction Therapy |
Primary outcome
Change in Child Behavior Problems
Time frame: baseline, first follow-up (up to 2 years)
parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.
1 secondary outcome
Aggregate Cost
Time frame: through end of study (up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30768419Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.
- Derived from this study: PubMed 24581245Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.
- Individual participant dataSharing planned: No. No data sharing plan was developed.
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Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
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Hybrid Pilot of Personalized Parent-Child Interaction Therapy
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Self-Concept Reinforcement for Early School Readiness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Gross, DNSc principal investigator
Johns Hopkins University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chicago Parent Program and Parent-Child Interaction Therapy in people with Behavior Problems, Child, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Behavior Problems (time frame: baseline, first follow-up (up to 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.